Efecto sistémico de la Inteligencia Artificial en el Bienestar Integral en Argentina: un Modelo Multidimensional y Culturalmente Adaptado Basado en SAMHSA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months
研究概览
简要总结
This study will evaluate the effect of an artificial intelligence-supported digital wellbeing platform, Wellbeing All-In-One (WAIO), on multidimensional wellbeing in adults living in Argentina.
The study includes an initial phase to evaluate and refine a culturally adapted wellbeing questionnaire based on the eight dimensions of the SAMHSA wellness framework. It will then conduct a randomized controlled trial in which participants are assigned to either immediate access to the WAIO platform or an active waitlist control group.
Participants will be followed for six months. The study will examine changes in self-reported wellbeing across physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental dimensions, as well as engagement, retention, and safety.
详细描述
This study uses a sequential mixed-method design consisting of an instrumental calibration phase followed by a two-arm, parallel randomized controlled trial.
During the initial instrumental phase, the preliminary 40-item WAIO Integral Wellbeing Inventory, culturally adapted from the SAMHSA eight-dimension wellness framework, will undergo psychometric evaluation. The first approximately 200 participants completing the baseline assessment will contribute to this phase. The planned evaluation includes assessment of internal consistency, factorial structure, convergent validity, comprehensibility, and test-retest reliability. Items retained after this prespecified calibration process will be used for subsequent longitudinal assessments.
The experimental phase will evaluate a digital wellbeing intervention delivered through the Wellbeing All-In-One (WAIO) progressive web application. WAIO integrates more than 30 interconnected digital tools organized around eight dimensions of wellbeing: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental. Artificial intelligence is used to personalize aspects of the user experience.
A total recruitment target of 2,000 adults in Argentina is planned. Participants entering the randomized phase will be allocated to one of two parallel groups. Participants in the immediate-intervention group will receive access to WAIO and weekly engagement messages. Participants in the active waitlist control group will receive general health information monthly and will not receive access to WAIO during the six-month comparison period. Access to WAIO will be provided to the waitlist group after completion of that period.
Participants will be assessed at baseline and followed longitudinally over six months. The study is designed to evaluate the trajectory of multidimensional wellbeing, the relationship between exposure to the digital intervention and changes in wellbeing, participant retention, and intervention safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Current residence in the Republic of Argentina, verified through an Argentine telephone prefix (+54).
- •Demonstrated functional digital competence, defined as the ability to independently complete the digital onboarding process, including QR code scanning, two-factor identity validation, and the baseline assessment.
- •Provision of digital informed consent.
排除标准
- •Age younger than 18 years.
- •Current residence outside the Republic of Argentina or inability to verify Argentine residence through the required telephone validation.
- •Inability to independently complete the required digital onboarding process.
- •Failure or refusal to provide digital informed consent.
研究组 & 干预措施
Immediate WAIO Access
Participants assigned to this arm will receive immediate access to the Wellbeing All-In-One (WAIO) progressive web application for the 6-month study period. They will also receive one weekly WhatsApp message encouraging engagement with the platform. WAIO integrates more than 30 interconnected digital tools organized across eight dimensions of wellbeing: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental.
干预措施: WAIO Multidimensional Digital Wellbeing Intervention (Behavioral)
Active Waitlist Control
Participants assigned to this arm will not receive access to the WAIO platform during the 6-month comparison period. They will receive one general health information message per month through WhatsApp. After completion of the 6-month comparison period, participants will be offered access to WAIO beginning in month 7.
干预措施: General Health Information Messages (Behavioral)
结局指标
主要结局
Change in WAIO Integral Wellbeing Standardized Score From Baseline to 6 Months
时间窗: Baseline and 6 months
The WAIO Integral Wellbeing Inventory assesses self-reported wellbeing across eight dimensions based on the SAMHSA wellness framework: physical, emotional, social, occupational, spiritual, financial, intellectual, and environmental wellbeing. A standardized overall score ranging from 0 to 100 will be calculated, with higher scores indicating higher integral wellbeing. Longitudinal scoring will use the items retained after the prespecified psychometric calibration phase.
次要结局
- Change in WAIO Integral Wellbeing Standardized Score From Baseline to 3 Months(Baseline and 3 months)
- Change in the Eight Dimension-Specific WAIO Wellbeing Scores(Baseline, 3 months, and 6 months)
- Change in Self-Rated General Health(Baseline, 3 months, and 6 months)
- Participant Retention Rate at 3 and 6 Months(3 months and 6 months)
- Incidence of Adverse Events and Serious Adverse Events(From baseline through 6 months)
- Correlation Between WAIO Exposure and Change in Multidimensional Wellbeing(From baseline through 6 months)
研究者
Leonardo Martin Barral
Doctoral Student in Systemic Innovation Management
Instituto Tecnológico de Buenos Aires